Health Trials

Tumoral Versus Luminal Microbiome in Head and Neck Squamous Cell Carcinoma

ConditionSquamous Cell Cancer of Head and Neck (SCCHN)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Sud Francilien

About this trial

Head and neck squamous cell carcinoma (HNSCC), France's 5th most common cancer (15,000 annual cases), presents significant public health challenges due to high morbidity and functional/aesthetic sequelae from treatments (mutilating surgery, radiotherapy, chemotherapy). Major risk factors, tobacco and alcohol, create a chronic inflammatory environment promoting tumor development. The upper aerodigestive tract microbiome, influenced by these exposures and local alterations (necrosis, bleeding, ulcerations), is emerging as a potential factor in tumor progression, severity biomarker, or therapeutic target, though its exact role (cause or consequence) remains to be elucidated

Objectives:

* Primary: Compare bacterial microbiome composition between tumor tissue, adjacent healthy mucosa, and pharyngeal secretions * Secondary: * Correlate microbiome diversity/composition with clinical and epidemiological characteristics * Identify microbiome variations by tumor stage, histology, and infiltration * Discover diagnostic/prognostic microbial markers * Analyze somatic variants (SNP/CNV) via whole-genome sequencing (WGS) and their association with microbiome profiles and clinical parameters

Study Design: Prospective, cross-sectional study with paired design (each patient serves as their own control to minimize genetic variation biases)

Methods:

* Samples: Tumor, adjacent healthy tissue, and pharyngeal secretions (3 samples/patient) * Sequencing: Metagenomic sequencing (complete bacterial genomes) when biomass permits, or targeted 16S rRNA sequencing to identify dominant genera. * Pilot study: 20 patients to select the optimal technique and validate feasibility, particularly assessing DNA quantity in these low-biomass environments

Population: Adults with suspected HNSCC scheduled for panendoscopy

Exclusion criteria: Recent antibiotics/corticosteroids (12 weeks), immunosuppression (uncontrolled HIV, active hematologic malignancies, autoimmune diseases on immunosuppressants, organ/stem cell transplants, uncontrolled diabetes), immunomodulatory treatments (3 months), recurrence, pregnancy, non-French speakers, legal guardianship, or lack of social security.

Safety: No additional risks beyond standard panendoscopy.

Expected impact: This approach may pave the way for innovative diagnostic or therapeutic strategies based on microbiome modulation in HNSCC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patient

Consultation in the ENT department for suspected squamous cell carcinoma of the upper aerodigestive tract scheduled for panendoscopy

Patient has provided consent to participate in the study and signed an informed consent form

Disqualifiers

Antibiotic or corticosteroid therapy within 12 weeks prior to consultation

Uncontrolled HIV infection (CD4 < 200 cells/µL) (permanent exclusion)

Hematologic malignancies currently under treatment or not in complete remission for <2 years

Autoimmune diseases under immunosuppressive treatment

Trial design

Design model

Single group

Treatments tested in this trial

  • Tissue and secretion sampling via biopsy

    Diagnostic test

    Additional biopsies (beyond standard clinical practice) taken during panendoscopy to collect: * Tumor tissue * Adjacent healthy mucosa * Pharyngeal secretions These samples are used for microbiome analysis. head and neck squamous cell carcinoma Note: The panendoscopy itself is a standard clinical procedure, but the additional biopsies for research purposes represent the study-specific intervention.

  • Tissue and secretion sampling via biopsy

    Procedure/Surgery

    Additional biopsies (beyond standard clinical practice) taken during panendoscopy to collect: * Tumor tissue * Adjacent healthy mucosa * Pharyngeal secretions These samples are used for microbiome analysis. head and neck squamous cell carcinoma Note: The panendoscopy itself is a standard clinical procedure, but the additional biopsies for research purposes represent the study-specific intervention.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Microbiome in head and neck squamous cell carcinoma PatientsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

The difference in bacterial composition between the tumor, healthy mucosa, and hypopharyngeal secretions will be assessed

Time frame
at day 1

Secondary outcomes

1

Correlations between tumor microbiome diversity and composition and clinical/epidemiological data

tumor microbiome diversity (by sequencing) tumor microbiome composition (by sequencing)

Time frame
at day 1
2

Differences in the tumor microbiome between subgroups defined by tumor stage, histological type, or infiltration, using differentiation tests

Time frame
at day 1
3

Differential bacterial genera or strains between tumor, healthy, and pharyngeal microbiomes

Time frame
at day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Sud Francilien

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: